Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children

This study has been completed.

Sponsor:

MedImmune LLC

ClinicalTrials.gov Identifier:

NCT00192205

First Posted: September 19, 2005

Last Update Posted: October 3, 2006

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine

Secondary Outcome Measures:

To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype

To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media

To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs

Estimated Enrollment:

2200

Study Start Date:

October 2002

Estimated Study Completion Date:

June 2003

Detailed Description:

The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age.

The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

6 Months to 71 Months (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

who are aged at least 6 months and less than 72 months of age at the time of enrolment;

who have experienced two or more practitioner attended RTIs* in the past 12 months (since birth if less than 12 months old); * RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia.

whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;

who, along with their parent(s)/legal guardian(s), will be available for duration of the trial;

whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria:

whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;

with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;

with Down's syndrome or other known cytogenetic disorders;

with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27;

who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;

for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrolment through to the conclusion of the study;

who have an immunosuppressed or an immunocompromised individual living in the same household;

who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) or is anticipated to receive a non-study influenza vaccine after enrollment;

with a documented history of hypersensitivity to egg or egg protein or any other component of CAIV-T or TIV;

who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment or for which use is anticipated during the study;

with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results;

Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrolment or ongoing participation of the subject in the study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192205